The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic colorectal cancer, treated in palliative intention in daily routine practice in Germany.
AZURITE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic colorectal cancer in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life (HRQoL) will be evaluated for up to three years.
Study Type
OBSERVATIONAL
Enrollment
500
Routine care as per site standard.
Multiple sites all over germany
Multiple Locations, Germany, Germany
Course of treatment (treatment reality).
Documentation of anamnestic data and therapy sequences.
Time frame: 3 years per patient.
Best Response.
Documentation of response rates per line of treatment.
Time frame: 3 years per patient.
Progression-free survival.
Documentation of progression-free survival per line of treatment.
Time frame: 3 years per patient.
Overall survival.
Documentation of overall survival per line of treatment.
Time frame: 3 years per patient.
Health-related quality of life (Patient-reported outcome, PRO).
EORTC QLQ-C30 core questionnaire \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems\].
Time frame: 3 years per patient.
Carcinoma Health-related quality of life (Patient-reported outcome, PRO).
EORTC QLQ-CR29 \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems\].
Time frame: 3 years per patient.
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